Study Comparing Different Neck Treatment Approaches in Patients With Oral Cancer Without Visible Neck Spread | NCT07726199

NCT07726199

Overview

NCT ID: NCT07726199
Lead Sponsor: Kolhapur Cancer Centre - Cancer Centers of AmericaOTHER
Official Title: ExteNT N0 Trial- Extent of Neck Treatment in Clinically N0 Oral Cancer: A Randomized Controlled Trial
Brief Summary: The goal of this clinical trial is to learn whether selective neck dissection involving lymph node levels I-III is as effective as selective neck dissection involving levels I-IV in treating adults with clinically node-negative (cN0) oral squamous cell carcinoma undergoing curative surgery. It will also evaluate whether extending the neck dissection to level IV affects cancer control, surgical complications, shoulder function, and quality of life. The main questions it aims to answer are:

Does selective neck dissection of levels I-III provide regional recurrence-free survival comparable to selective neck dissection of levels I-IV?

Does extending the neck dissection to level IV improve overall survival, disease-free survival, or reduce regional recurrence?

Does selective neck dissection of levels I-III result in less postoperative morbidity, better shoulder function, and improved quality of life compared with selective neck dissection of levels I-IV?

Researchers will compare patients undergoing selective neck dissection of levels I-III with those undergoing selective neck dissection of levels I-IV to determine whether routine removal of level IV lymph nodes provides additional oncological benefit while maintaining acceptable functional outcomes.

Participants will:

Undergo surgery for oral squamous cell carcinoma with random assignment to selective neck dissection of either levels I-III or levels I-IV.

Receive standard postoperative treatment, including radiotherapy or chemoradiotherapy when indicated according to the final pathology report.

Attend scheduled follow-up visits for clinical examinations and surveillance for cancer recurrence.

Undergo assessments of shoulder function, sensory function, postoperative complications, and quality of life using validated questionnaires at predefined follow-up intervals.

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 24, 2026Actual
Start Date: Apr 22, 2026Actual
Primary Completion Date: Sep 1, 2030Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Patients aged over 21 years will be included.

Histologically proven squamous cell carcinoma of oral cavity will be included

Clinical stage T1-T4, N0, M0

cN0 neck on clinical examination and imaging (CT/MRI)

American Society of Anesthesiologists (ASA) Physical Status I or II

Understands the protocol

and can give informed consent.

Exclusion Criteria:

Recurrent cases

FNAC proven Positive cervical nodes

Patients with history of head and neck radiation therapy treatment

Previous neck surgery or radiotherapy

Previous history of any cancer

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 267Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Maroti B Wadewale, MDS, FHNOContact
dr.marotiwadewale59@gmail.com+918483851334

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Participant Group/Arms

Arm 1- Selective neck dissection involving cervical lymph node levels I, II, and III.Active Comparator

The patients belongs to this group will undergo selective neck dissection level I to II, which will include: removal of lymph node Levels Ia, Ib, IIa and III. The contralateral neck will be addressed when the lesion reaches or crosses the midline, with the extent of dissection determined by the assigned study arm. Any intraoperatively obvious/suspicious lymph nodes will be sent for frozen section, and if positive, a modified neck dissection will be performed.

Procedure: Intervention : Selective Neck Dissection (Levels I-III)

Arm 2- Selective neck dissection level I, II, III and IVExperimental

The patients belongs to this group will undergo selective neck dissection level I to II, which will include: removal of lymph node Levels Ia, Ib, IIa, III and IV. The contralateral neck will be addressed when the lesion reaches or crosses the midline, with the extent of dissection determined by the assigned study arm. Any intraoperatively obvious/suspicious lymph nodes will be sent for frozen section, and if positive, a modified neck dissection will be performed.

Procedure: Selective Neck Dissection (Levels I-IV)